A Phase 3 interventional study of Macitentan in Pulmonary Arterial Hypertension, sponsored by Actelion. Terminated at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Actelion · Phase 3, Interventional, and Treatment
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Macitentan tablet, dose of 10 mg, once daily.
Drug: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Also known as: ACT-064992
Incident Rate of Adverse Events (AEs).
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
Time frame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).
All sites activated on the SYMPHONY AC-055-401 clinical trial were invited to participate in this open-label extension study. Due to meeting the study closure milestone, defined as the marketing of Opsumit on 18 OCT 2013, only two sites received activation. Recruitment occurred between Quarter 2 2013 and Quarter 3 2015.
| Milestone | Macitentan |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
| Milestone | Macitentan |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
| Participants | Macitentan |
|---|---|
| Participants with severe intensity AEs | 1 |
| Participants with AEs | 3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macitentan | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Event | Macitentan |
|---|---|
| Chronic Obstructive Pulmonary Disease ExacerbationRespiratory, thoracic and mediastinal disorders | 1/4 |
| Pulmonary Arterial Hypertension ExacerbationCardiac disorders | 1/4 |
| Pulmonary Hypertension ExacerbationCardiac disorders | 1/4 |
| Right Heart FailureCardiac disorders | 1/4 |
| Event | Macitentan |
|---|---|
| HyperlipidaemiaMetabolism and nutrition disorders | 1/4 |
| HypokalaemiaMetabolism and nutrition disorders | 1/4 |
| Type 2 Diabetes MellitusMetabolism and nutrition disorders | 1/4 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/4 |
| Right Heart FailureCardiac disorders | 1/4 |
| VertigoEar and labyrinth disorders | 1/4 |
| DiarrhoeaGastrointestinal disorders | 1/4 |
| NauseaGastrointestinal disorders | 1/4 |
| VomitingGastrointestinal disorders | 1/4 |
| Chest PainGeneral disorders | 1/4 |
A total of four participants enrolled directly from the parent clinical trial, SYMPHONY AC-055-401 (NCT01841762). There was only one arm associated with the Extension study.
| Age, Categorical(Participants) | Macitentan |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Age, Continuous(Years) | Macitentan |
|---|---|
| Mean | 60.8 (55.0 to 66.5) |
| Sex: Female, Male(Participants) | Macitentan |
|---|---|
| Female | 4 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Macitentan |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Macitentan |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
Actelion